A Legislative History of the Federal Food, Drug, and Cosmetic Act and Its ...

FEDERAL FOOD, DRUG, AND COSMETIC ACT

following food industry organizatious: American Bakers' Association, American Institute of Baking, American Meat Institute, Dairy Industry Committee, Millers' National Federation.

For convenience I shall refer to H. R. 8275 and H. R. S271, respectively, as the Priest-O Hara bills.

On the basic question involved in this legislation, i. e., whether there is need for it, all parties agree. It is a remarkable fact that the numerous industries most vitally affected are supporting legislation which will subject their members to complex and expensive governmental regulation and will impose severe penalties for falure to comply.

The most important fundamental issue in controversy before the committee is whether in this broad area of important legislation an administrative agency shall be vested with judicial powers which constitutionally are vested in the courts. The need for the legislation being admitted, it would indeed be regrettable if the gains to be realized therefrom can be realized only at the expense of further inroads on the constitutional doctrine of separation of powers.

UNWARBANTED CONFUSION

The fundamental issue has been beclouded by the injection of a number of contentions and objections of relative unimportance and uniform unsoundness, which I shall first discuss.

The "burden” of filing suits

It has been argued by the Food and Drug Administration that under the Priest-O'Hara bills FDA would as a practical matter have to initiate and prosecute a suit in every case in which the Secretary issues an opinion that an additive has not been adequately pietested to show its safety; and a great deal of the time of the committee and the witnesses was taken by this argument.

Even if the bills were to be enacted in the exact form introduced, the argument is unsound. The bills provide that the additive can in no event be used within a period of 60 days after an unfavorable opinion by the Secretary, and further, that if a suit is instituted, the additive cannot be used until a fiual determination of the suit in favor of the proponent. After the expiration of the 60-day period without the filing of a suit, the proponent can use the additive only at his peril. If he should use it FDA can immediately institute proceedings at any time, whether days, months, or years after the unfavorable opinion, and these proceedings can be by declaratory judgment action or by an injunction suit or by libel and condemnation. Similarly, the Department of Justice could prosecute criminally at any time after such use. It is absurd to assume that any appreciable number of manufacturers would use an additive carrying the stamp of disapproval of FDA without first obtaining a court judgment establishing its safety, or that FDA would be so impractical as to institute a suit without reasonable cause to believe that the proponent is using or intends to use the additive.

However, this alleged objection can be effectively disposed of by the committee, and could have been eliminated as a supposed controversial Issue by FDA, by the adoption of a simple change in the Priest-O'Hara bills which stated in my testimony would be acceptable to the food industries for which I speak, and which was also recommended by Mr. Gillett, testifying for the Manufacturing Chemists' Association, Inc., and by Mr. Dunn, testifying for Grocery Manufacturers of America. The change would consist of an added provision to the effect that after an unfavorable opinion by the Secretary the proponent may not use the additive without first giving to the Secretary at least 30 days notice of intended use, which would enable the Secretary to institute any type of legal action which he deems advisable before the use

occurs.

This would effectively dispose of the contention that FDA would not know whether a manufacturer intends to use the additive after an unfavorable opinion and would therefore have to file a suit in every case in order to prevent the introduction of the additive in interstate commerce.

This suggestion of prior notice of intended use was made by various industry .witnesses on February 1, 2, and 3 in the presence of FDA representatives, yet almost 2 weeks later FDA witnesses took the stand, ignored the sugestion, and argued the case as if it had not been made. Much time was spent aud much confusion resulted, all of which could and should have been avoided.

FEDERAL FOOD, DRUG, AND COSMETIC ACT

The question of "scientific judgment"

In his report to this committee dated February 1, 1956, the Secretary of Health, Education, and Welfare based the preference of the Food and Drug Administration for the administrative hearing procedure in part on the ground that "the courts would be required to exercise a difficult scientific • • • judg ment" which they are not equipped to exercise. Much has been made of this argument by witnesses who support the views of the Food and Drug Administration, but the argument, which at first glance may seem logical, upon analysis proves to be unsound.

It should be borne in mind that the scientific judgment of the staff of the Food and Drug Administration would be exercised in the first instance in reviewing the pretesting data submitted and in determining whether to issue a favorable or an unfavorable opinion. As demonstrated in my original testimony, this opinion of the Secretary would prevail, unchallenged in any kind of hearing, in all but a negligible number of cases. It is only when the manufacturer is so sure of his ground that he feels it imperative to appeal from this initial decision that any formal hearing of any kind would be had, and it is only at that point that the question of administrative hearing versus court proceeding comes into existence.

Under the administrative hearing procedure, the Secretary would first promulgate a regulation respecting an additive, after which, upon objection by an interested party, a formal administrative hearing, similar to a trial, would be conducted by the Secretary, on the basis of which the Secretary would issue detailed findings of fact and a formal order. Court review would be by appeal to the court of appeals and the Secretary's findings of fact would be binding on the court if supported by "substantial" evidence.

The question naturally arises: What scientific judgment would a court be required to exercise in a declaratory judgment proceeding which the Secre tary would not be required to exercise in an administrative hearing? The answer is "None".

The next question is: What scientific or professional training does the Seeretary of Health, Education, and Welfare possess-bearing in mind that he is not required to be either a scientist or a lawyer-which makes him better qualified to determine credibility of witnesses and weigh evidence than a judge trained and experienced in such matters? The answer is "None."

However, the Assistant General Counsel for the Department of Health, Education, and Welfare, in response to questions of this nature, testified orally that the Secretary would not actually make the decision, but, instead, that it would be made by the staff of the Food and Drug Administration. If this is true, then the administrative hearing which FDA recommends would not give the manufacturer a fair trial.

The situation would differ from that in the customary administrative hearing. Here the staff of FDA prior to the hearing would have reviewed all of the pre testing data on the additive, on the basis of which the Secretary would theretofore have issued and unfavorable opinion. It is not to be expected that these same staff members would or could then cast out their own personal views disregard their own opinions, and impartially weigh the evidence introduced in a formal administrative hearing and reach a just and impartial decision on the record.

Whether the issues be tried before a court or before the Secretary, the law requires that the decision be made on the evidence in the record. Independent, impartial judges, trained in making such decisions and subservient to no master but the law, are best qualified for the purpose. The issues would be no more technical nor complex than in many other cases coming before them; and they would approach the subject without prejudice or prejudgment.

Moreover, under the administrative hearing procedure, if court review is bad the court of appeals must still review the record to determine whether the administrative decision is supported by substantial evidence. To make this determination the appellate judges must work from the record alone, with no opportunity, such as the trial judge would have, to see and hear the witnesses and obtain explanations of any technical matter upon which further light is desired. If the judges of the court of appeals can make such determination from a cold record and unless they can do so an appeal is futile and the right of appeal is meaningless-then certainly a trial judge can make it in the first instance.

The industries affected deem it vitally important, in order to guard against an unreasonable or arbitrary opinion by the agency or the adequacy of the pretesting data submitted, that the issues may be tried initially in an impartial

FEDERAL FOOD, DRUG, AND COSMETIC ACT

following food industry organizations: American Bakers' Association, American Institute of Baking, American Meat Institute, Dairy Industry Committee, Millers' National Federation.

For convenience I shall refer to H. R. 8275 and H. R. S271, respectively, as the Priest-O Hara bills.

UNWARRANTED CONFUSION

The fundamental issue has been beclouded by the injection of a number of contentions and objections of relative unimportance and uniform unsoundness, which I shall first discuss.

The "burden" of filing suits

It has been argued by the Food and Drug Administration that under the Priest-O'Hara bills FDA would as a practical matter have to initiate and prosecute a suit in every case in which the Secretary issues an opinion that an additive has not been adequately pretested to show its safety; and a great deal of the time of the committee and the witnesses was taken by this argument.

Even if the bills were to be enacted in the exact form introduced, the argument is unsound. The bills provide that the additive can in no event be used within a period of 60 days after an unfavorable opinion by the Secretary, and further, that if a suit is instituted, the additive cannot be used until a final determination of the suit in favor of the proponent. After the expiration of the 60-day period without the filing of a suit, the proponent can use the additive only at his peril. If he should use it FDA can immediately institute proceedings at any time, whether days, months, or years after the unfavorable opinion, and these proceedings can be by declaratory judgment action or by an injunction suit or by libel and condemnation. Similarly, the Department of Justice could prosecute criminally at any time after such use. It is absurd to assume that any appreciable number of manufacturers would use an additive carrying the stamp of disapproval of FDA without first obtaining a court judgment establishing its safety, or that FDA would be so impractical as to institute a suit without reasonable cause to believe that the proponent is using or intends to use the additive.

However, this alleged objection can be effectively disposed of by the committee, and could have been eliminated as a supposed controversial issue by FDA, by the adoption of a simple change in the Priest-O'Hara bills which stated in my testimony would be acceptable to the food industries for which I speak, and which was also recommended by Mr. Gillett, testifying for the Manufacturing Chemists' Association, Inc., and by Mr. Dunn, testifying for Grocery Manufacturers of America. The change would consist of an added provision to the effect that after an unfavorable opinion by the Secretary the proponent may not use the additive without first giving to the Secretary at least 30 days notice of intended use, which would enable the Secretary to institute any type of legal action which he deems advisable before the use

occurs.

This suggestion of prior notice of intended use was made by various industry witnesses on February 1, 2, and 3 in the presence of FDA representatives, yet almost 2 weeks later FDA witnesses took the stand, ignored the sugges tion, and argued the case as if it had not been made. Much time was spent aud much confusion resulted, all of which could and should have been avoided.

FEDERAL FOOD, DRUG, AND COSMETIC ACT

The question of "scientific judgment"

In his report to this committee dated February 1, 1956, the Secretary of Health, Education, and Welfare based the preference of the Food and Drug Administration for the administrative hearing procedure in part on the ground that "the courts would be required to exercise a difficult scientific ・・・ judg ment" which they are not equipped to exercise. Much has been made of this argument by witnesses who support the views of the Food and Drug Administration, but the argument, which at first glance may seem logical, upon analysis proves to be unsound.

Under the adminiștrative hearing procedure, the Secretary would first proulgate a regulation respecting an additive, after which, upon objection by an interested party, a formal administrative hearing, similar to a trial, would be conducted by the Secretary, on the basis of which the Secretary would issue detailed findings of fact and a formal order. Court review would be by appeal to the court of appeals and the Secretary's findings of fact would be binding on the court if supported by "substantial" evidence.

The next question is: What scientific or professional training does the See retary of Health, Education, and Welfare possess-bearing in mind that he is not required to be either a scientist or a lawyer-which makes him better qualified to determine credibility of witnesses and weigh evidence than a judge trained and experienced in such matters? The answer is "None."

The situation would differ from that in the customary administrative hearing.· Here the staff of FDA prior to the hearing would have reviewed all of the pretesting data on the additive, on the basis of which the Secretary would theretofore have issued and unfavorable opinion. It is not to be expected that these same staff members would or could then cast out their own personal views, disregard their own opinions, and impartially weigh the evidence introduced in a formal administrative hearing and reach a just and impartial decision on the record.

Moreover, under the administrative hearing procedure, if court review is bad the court of appeals must still review the record to determine whether the administrative decision is supported by substantial evidence. To make this determination the appellate judges must work from the record alone, with no opportunity, such as the trial judge would have, to see and hear the witnesses and obtain explanations of any technical matter upon which further light is desired. If the judges of the court of appeals can make such determination from a cold record—and unless they can do so an appeal is futile and the right of appeal is meaningless-then certainly a trial judge can make it in the first instance.

FEDERAL FOOD, DRUG, AND COSMETIC ACT

following food industry organizations: American Bakers' Association, American Institute of Baking, American Meat Institute, Dairy Industry Committee, Millers' National Federation.

For convenience I shall refer to H. R. 8275 and H. R. S271, respectively, as the Priest-O Hara bills.

UNWARRANTED CONFUSION

The fundamental issue has been beclouded by the injection of a number of contentious and objections of relative unimportance and uniform unsoundness, which I shall first discuss.

The “burden” of filing suits

It has been argued by the Food and Drug Administration that under the Priest-O'Hara bills FDA would as a practical matter have to initiate and prosecute a suit in every case in which the Secretary issues an opinion that an additive has not been adequately pretested to show its safety; and a great deal of the time of the committee and the witnesses was taken by this argument.

Even if the bills were to be enacted in the exact form introduced, the argument is unsound. The bills provide that the additive can in no event be used within a period of 60 days after an unfavorable opinion by the Secretary, and further, that if a suit is instituted, the additive cannot be used until a final determination of the suit in favor of the proponent. After the expiration of the 60-day period without the filing of a suit, the proponent can use the additive only at his peril. If he should use it FDA can immediately institute proceedings at any time, whether days, months, or years after the unfavorable opinion, and these proceedings can be by declaratory judgment action or by an injunction suit or by libel and condemnation. Similarly, the Department of Justice could prosecute criminally at any time after such use. It is absurd to assume that any appreciable number of manufacturers would use an additive carrying the stamp of disapproval of FDA without first obtaining a court judgment establishing its safety, or that FDA would be so impractical as to institute a suit without reasonable cause to believe that the proponent is using or intends to use the additive.

occurs.

This suggestion of prior notice of intended use was made by various industry .witnesses on February 1, 2, and 3 in the preseuce of FDA representatives, yet almost 2 weeks later FDA witnesses took the stand, ignored the sugges tion, and argued the case as if it had not been made. Much time was spent aud much confusion resulted, all of which could and should have been avoided.

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